^
    3d
    Phase I trial of intravenous VCN-01 oncolytic adenovirus and durvalumab in patients with head and neck metastatic squamous cell carcinoma refractory to immunotherapy. (PubMed, Clin Cancer Res)
    Sequential VCN-01 plus durvalumab was better tolerated than concomitant treatment. The recommended VCN-01 phase 2 dose (RP2D) was 1.0E13 vp, on the sequential schedule. Encouraging survival was observed in patients after progressing on anti-PD-(L)1 agents. Data supports VCN-01 replication associated with increased PD-1, PD-L1, and CD8 tumor expression. Sequential systemic delivery of VCN-01 and anti-PD-L1 therapy may represent an improved treatment for HNSCC.
    P1 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1)
    |
    PD-L1 expression
    |
    Imfinzi (durvalumab) • zabilugene almadenorepvec (VCN-01)
    1year
    VIRAGE: Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=112, Completed, Theriva Biologics SL | Active, not recruiting --> Completed
    Trial completion
    |
    gemcitabine • albumin-bound paclitaxel • zabilugene almadenorepvec (VCN-01)
    over1year
    huCART-meso + VCN-01 in Pancreatic and Ovarian Cancer (clinicaltrials.gov)
    P1, N=13, Active, not recruiting, University of Pennsylvania | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    zabilugene almadenorepvec (VCN-01)
    over1year
    VIRAGE: Study of Nab-Paclitaxel and Gemcitabine and Plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=96, Active, not recruiting, Theriva Biologics SL | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • zabilugene almadenorepvec (VCN-01)
    almost2years
    RTB: Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma (clinicaltrials.gov)
    P=N/A, N=13, Completed, Fundació Sant Joan de Déu | Active, not recruiting --> Completed
    Trial completion • Oncolytic virus
    |
    RB1 (RB Transcriptional Corepressor 1)
    |
    zabilugene almadenorepvec (VCN-01)
    2years
    RTB: Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma (clinicaltrials.gov)
    P=N/A, N=13, Active, not recruiting, Fundació Sant Joan de Déu | Recruiting --> Active, not recruiting | Phase classification: P1 --> PN/A | Trial completion date: Jun 2022 --> Jul 2024 | Trial primary completion date: Jun 2022 --> Jun 2024
    Enrollment closed • Phase classification • Trial completion date • Trial primary completion date • Oncolytic virus
    |
    RB1 (RB Transcriptional Corepressor 1)
    |
    RB1 mutation
    |
    zabilugene almadenorepvec (VCN-01)
    over2years
    VIRAGE: Study of Nab-Paclitaxel and Gemcitabine and Plus/Minus VCN-01 in Patients With Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=96, Recruiting, Theriva Biologics SL | Phase classification: P2b --> P2
    Phase classification • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • zabilugene almadenorepvec (VCN-01)
    over2years
    Oncolytic virotherapies for pediatric tumors. (PubMed, Expert Opin Biol Ther)
    We reviewed seven virus types that have been investigated in past or ongoing pediatric tumor clinical trials: adenovirus (AdV-tk, Celyvir, DNX-2401, VCN-01, Ad-TD-nsIL-12), herpes simplex virus (G207, HSV-1716), vaccinia (JX-594), reovirus (pelareorep), poliovirus (PVSRIPO), measles virus (MV-NIS), and Senecavirus A (SVV-001). However, the antitumor effects of OVT remain variable depending on tumor type and viral agent used. Although the widespread adoption of OVT faces many challenges, we are optimistic that OVT will play an important role alongside standard chemotherapy and radiotherapy for the treatment of malignant pediatric solid tumors in the future.
    Review • Journal • Oncolytic virus
    |
    ProstAtak (aglatimagene besadenovec) • Reolysin (pelareorep) • tasadenoturev (DNX-2401) • HSV G207 • MV-NIS • Pexa-Vec (pexastimogene devacirepvec) • SVV-001 • Seprehvir (HSV1716) • zabilugene almadenorepvec (VCN-01)
    almost3years
    Survival outcomes in phase I trial combining VCN-01 and durvalumab (MEDI4736) in subjects with recurrent/metastatic head and neck squamous cell carcinoma refractory to previous immunotherapy treatment (ESMO 2023)
    Conclusions Encouraging survival was observed in patients progressing to anti-PD(L)-1 agents after systemic VCN-01 with Durvalumab. VCN-01-induced upregulation of PD-L1, which correlated with enhanced patient survival.
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8)
    |
    Imfinzi (durvalumab) • zabilugene almadenorepvec (VCN-01)
    4years
    Phase I, multicenter, open-label study of intravenous VCN-01 oncolytic adenovirus with or without nab-paclitaxel plus gemcitabine in patients with advanced solid tumors. (PubMed, J Immunother Cancer)
    Treatment with VCN-01 is feasible and has an acceptable safety. Encouraging biological and clinical activity was observed when administered in combination with nab-paclitaxel plus gemcitabine to patients with pancreatic adenocarcinoma.
    Journal • Oncolytic virus
    |
    RB1 (RB Transcriptional Corepressor 1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • LAG3 (Lymphocyte Activating 3) • IL10 (Interleukin 10)
    |
    gemcitabine • albumin-bound paclitaxel • zabilugene almadenorepvec (VCN-01)
    4years
    RTB: Evaluate Safety and the Oncolitic Adenovirus VCN-01 Activity in Patients With Refractory Retinoblastoma (clinicaltrials.gov)
    P1, N=13, Recruiting, Fundació Sant Joan de Déu | Trial completion date: Apr 2021 --> Jun 2022 | Trial primary completion date: Sep 2020 --> Jun 2022
    Trial completion date • Trial primary completion date • Oncolytic virus
    |
    RB1 (RB Transcriptional Corepressor 1)
    |
    RB1 mutation
    |
    zabilugene almadenorepvec (VCN-01)
    4years
    Safety,Tolerability,and Efficacy of VCN-01 With Durvalumab in R/M Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, Institut Català d'Oncologia | Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> Jan 2023 | Trial primary completion date: Sep 2021 --> Jan 2023
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    IL6 (Interleukin 6) • IL10 (Interleukin 10)
    |
    Imfinzi (durvalumab) • zabilugene almadenorepvec (VCN-01)